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Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

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ClinicalTrials.gov Identifier: NCT04460950
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
Observational study aimed at evaluating the incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (< 40 years)

Condition or disease
Acute Myeloid Leukemia Familial Acute Myeloid Leukemia Myelodysplastic Syndromes

Detailed Description:

This is a multicenter, retrospective and prospective, observational study aims to collect clinical information on patients with familial AML/MDSs from January 2014 to December 2022. No intervention is expected.

The purpose of this study is to identify and characterize the patients with familial MDSs or AML (i.e. with relatives affected by hematologic neoplasms and/or other cancers at young age (< 40 years)) or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs.

In order to estimate the incidence of familial AML/MDSs, a survey will be sent every year to all participating sites to collect only the number of the all diagnosis of AML/MDS. All patients will be followed until December 2023 in order to have at least 1 year of observation.

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Study Type : Observational
Estimated Enrollment : 237 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024





Primary Outcome Measures :
  1. Incidence of familial AML/MDSs [ Time Frame: at 1 year ]
    Evaluation of incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (< 40 years). The incidence of familial AML/MDSs will be evaluated by means of number of diagnosis of familial AML/MDSs on the number of all diagnosis of AML/MDS between January 2014 and December 2022.


Secondary Outcome Measures :
  1. Hematological characteristics of familial AML/MDSs [ Time Frame: at 1 year ]
    Evaluation of hematological characteristics of patients with familial AML/MDS.

  2. Distribution of familial hematologic neoplasms and/or other cancers [ Time Frame: at 1 year ]
    Type and rate of familial hematologic neoplasms and/or other cancers

  3. Incidence of transplantation [ Time Frame: at 1 year ]
    Outcome of transplant in patients with familial AML/MDS

  4. Survival Distribution [ Time Frame: at 1 year ]
    Overall Survival (OS) and Progression Free Survival (PFS)

  5. Standardized Mortality Ratio (SMR) [ Time Frame: at 1 year ]
    SMR to compare the survival risk in patients with familial AML/MDS with the risk in the Italian general population



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnoses with AML and MDSs from January 2014 to December 2022 will be registered. Study population will include patients with MDSs or AML with at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age < 40 years.
Criteria

Inclusion Criteria:

  • Patient age > 18 years old
  • Diagnosis of AML or MDSs from January 2014 to December 2022
  • Suspected familiarity for myeloid neoplasm: at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age < 40 years or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs
  • Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460950


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Locations
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Italy
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia Recruiting
Brescia, Italy
Contact: Domenico Russo         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04460950    
Other Study ID Numbers: AML2120
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases